REHOVOT, Israel, April 05, 2022 (GLOBE NEWSWIRE) — Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, today announced that the efficacy and safety data from its recently completed Phase 3, randomized controlled trial of P2B001 in the management of early Parkinson’s disease is being presented today, April 5th, as an oral presentation in the Emerging Science late-breaking session at the American Academy of Neurology (AAN) annual meeting in Seattle.
“We are honored that the positive outcomes from our Phase 3 study of P2B001 in early Parkinson’s patients was chosen for oral presentation at the AAN annual meeting,” said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. “Early Parkinson’s patients need a treatment option that can significantly improve motor symptoms and daily function, while avoiding side effects, such as daytime sleepiness, orthostatic hypotension and hallucinations associated with higher doses of dopamine agonists. The Phase 3 data on P2B001 suggest that it can address these challenges.”
P2B001 is a novel once daily combination of extended-release (ER) formulations of a low dose dopamine agonist, pramipexole, and a low dose MAO-B inhibitor, rasagiline, that appears to increase striatal dopaminergic transmission via distinct and potentially synergistic mechanisms. As such, if approved, P2B001 may offer a therapy with improved benefit risk ratio between efficacy and safety for Parkinson’s disease patients. Of note, the low doses utilized in P2B001 are not currently available on the market and the ER rasagiline is a proprietary dosage form.
Pharma Two B recently reported that P2B001 met its primary and key secondary endpoints in a Phase 3 pivotal study. The results demonstrated that P2B001 has symptomatic benefits comparable to higher doses of marketed pramipexole ER, yet with less dopaminergic side effects and significantly less daytime sleepiness. P2B001’s efficacy was also significantly superior to its components. For more information on the trial, refer to ClinicalTrials.gov Identifier: NCT03329508
Dr. Warren Olanow, Professor Emeritus in the Departments of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York and CEO of Clintrex Research Corporation said, “We are very pleased to share the positive data from our well-designed, rigorous, active-controlled Phase 3 study of P2B001 with the many neurologists who are attending AAN. P2B001 has the potential to become a leading treatment option for patients with Parkinson’s disease, particularly as first line therapy for early-stage patients of all ages. If approved, P2B001 will enable patients to be treated with a once-daily effective therapy that requires no titration while minimizing the dopaminergic side effects and daytime sleepiness often seen with this class of drugs.”
Phase 3 study results
The multicenter, randomized, double-blind, parallel group Phase 3 study evaluated 544 patients with Parkinson’s disease to determine in patients with early untreated Parkinson’s disease, the efficacy and safety of P2B001 once-daily compared to its individual components. Eligible patients, those 35-80-year-olds, were randomized (2:2:2:1) to 12-weeks treatment with P2B001, pramipexole 0.6mg, rasagiline 0.75mg or marketed titrated pramipexole-ER. The primary endpoint compared the change from baseline to week 12 in UPDRS scores for P2B001 versus its individual components. The key secondary endpoint compared the change from baseline in Epworth Sleepiness Scale (ESS) for P2B001 versus pramipexole-ER.
P2B001 provided significantly superior symptomatic efficacy compared to its individual components; mean ±SE change from baseline in UPDRS-Total scores were -7.98±0.60 points for the P2B001 group versus -5.32±0.61 for pramipexole (adjusted mean change in Total-UPDRS score from baseline was -2.66 points for P2B001 versus pramipexole, p=0.0018) and -4.69±0.61 for rasagiline (adjusted mean change in Total-UPDRS from baseline was -3.30 points for P2B001 versus rasagiline, p<0.0001). P2B001 showed significantly less daytime sleepiness than the marketed pramipexole-ER; mean±SE changes from baseline in ESS-Total scores were -0.33±0.25 for P2B001 versus 2.33±0.36 for pramipexole-ER (adjusted mean change in ESS score from baseline was -2.66 points for P2B001 versus pramipexole ER, p<0.0001). Fewer treatment related adverse events were reported with P2B001 versus pramipexole-ER (74.7% vs. 86.5%), including somnolence (14.7% vs 31.1%), orthostatic hypotension (2.7% vs 12.2%) and memory impairment (0% vs 5.4%).
Details of oral abstract presentation at AAN:
What: Oral, in-person presentation of abstract number 1082, entitled “Efficacy and safety of P2B001 in the management of early Parkinson’s disease. Results from a phase 3, randomized, double-blind, double-dummy controlled trial.”
Where: AAN Emerging Science Session at Washington State Convention Center, Seattle
When: Tuesday, April 5 from 11:30 a.m.to 12:45 p.m. PT
Who: Dr. Warren Olanow, Professor Emeritus of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai in New York
Virtual Meeting Presentation: Poster presentation April 24-26
About Pharma Two B
Pharma Two B is a clinical-stage pharmaceutical company that is developing differentiated and value-added products, based on reformulation and combinations of previously approved orally administered drugs for neurological indications. The company aims to improve efficacy, safety and delivery profiles that address unmet medical needs while minimizing timelines to FDA approval via the 505(b)(2) pathway. The company’s lead product P2B001 is being developed as a treatment for signs and symptoms of Parkinson’s disease. Pharma Two B has completed a Phase 3 trial with P2B001 and is preparing to file an NDA later this year. Pharma Two B is led by a highly experienced management team, supported by prominent scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com.
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